# SPOT-MAS

Source: https://onco.cc/drugs/spot-mas/  
OnCo record `spot-mas` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Gene Solutions' low-cost blood test from Vietnam; in 9,024 people without symptoms about one in two hundred tested positive and four in ten of those had cancer.

## Summary

In the prospective K-DETEK study (Nguyen et al., BMC Medicine 2025; NCT05227261) of 9,024 asymptomatic adults aged 40 or older at 75 Vietnamese hospitals, 43 (0.48%) tested positive and 17 had cancer: positive predictive value 39.53% (95% CI 26.37 to 54.42), tissue-of-origin accuracy 52.94%, sensitivity 70.83% (50.83 to 85.09) and specificity 99.71% over 12 months; no stage I figure is given. In the earlier case-control study (Nguyen et al., eLife 2023; 738 non-metastatic patients with five cancers, 1,550 controls) sensitivity was 72.4% at 97.0% specificity, 73.9% at stage I.

Gene Solutions announced FDA Breakthrough Device designation for SPOT-MAS 10, for ten cancers (breast, lung, liver, colorectal, gastric, ovarian, pancreatic, oesophageal, endometrial and head and neck) in asymptomatic adults aged 40 and over, on 27 May 2026, and says the test has been used in more than 100,000 people and that it targets US launch readiness in late 2026 (company statements). K-ACCELERATE (NCT06391749) tests it as a triage test in people with symptoms. No Vietnamese approval or price was found.

## Fields

- Kind: Treatment
- Status: emerging
- Last checked: 2026-10-29
- Also known as: Screening for the Presence Of Tumor by DNA Methylation And Size; SPOT-MAS 10
- Tags: test; mced; evidence:insufficient
- Brand: SPOT-MAS
- Modality: Multi-cancer early detection blood test (cell-free DNA methylation, fragment size, copy number)
- Mechanism: Targeted methylation and shallow whole-genome sequencing (about 0.55x) of cell-free DNA, reading methylation, fragment size, copy number and end motifs in one workflow, with a predicted tissue of origin.

## Notes

- Evidence grade insufficient for the claim that taking this test reduces late-stage diagnosis or cancer deaths: no randomised trial of it has reported either outcome, and its published performance comes from case-control or single-arm studies. The only randomised result for any multi-cancer test, NHS-Galleri, did not show fewer stage III or IV cancers.
- What a result means: a positive result is a reason for further tests, not a diagnosis; a negative result does not rule cancer out and does not replace the screening tests that have been shown to work (bowel, breast, cervical and, where eligible, lung screening).

## Sources

- Nguyen et al., BMC Medicine 2025 (K-DETEK): https://doi.org/10.1186/s12916-025-03929-y
- Nguyen et al., eLife 2023: https://doi.org/10.7554/eLife.89083

## Connected records

- technologies: [Cell-free DNA methylation tests](https://onco.cc/technologies/cfdna-methylation-testing/), [cfDNA fragmentomics](https://onco.cc/technologies/fragmentomics/), [Liquid biopsy (ctDNA)](https://onco.cc/technologies/liquid-biopsy/), [Multi-cancer early detection (MCED)](https://onco.cc/technologies/mced/)
- companies: [Gene Solutions](https://onco.cc/companies/gene-solutions/)
- trials: [K-ACCELERATE (SPOT-MAS in people with symptoms)](https://onco.cc/trials/k-accelerate/), [K-DETEK (SPOT-MAS in adults without symptoms, Vietnam)](https://onco.cc/trials/k-detek/)
- key papers: [Multimodal analysis of methylomics and fragmentomics in plasma cell-free DNA for multi-cancer early detection and localization](https://onco.cc/key-papers/paper-spot-mas-elife-2023/), [Prospective validation study: a non-invasive circulating tumor DNA-based assay for simultaneous early detection of multiple cancers in asymptomatic adults](https://onco.cc/key-papers/paper-spot-mas-k-detek-bmc-med-2025/)

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